Health Law Advisor

On Friday, June 14, the Texas Supreme Court declined to consider a case that asked the Court to determine whether frozen embryos are persons or property under Texas law.

In our ongoing series of blog posts, we have examined key negotiating points for tenants in triple net health care leases. We also have offered suggestions for certain lease provisions that will protect tenants from overreaching and unfair expenses, overly burdensome obligations, and ambiguous terms with respect to the rights and responsibilities of the parties. These suggestions are intended to result in efficient lease negotiations and favorable lease terms from a tenant’s perspective. In our previous posts, we considered the importance of negotiating initial terms and renewal terms, operating expense provisions, assignment and subletting terms, and maintenance and repair obligations. This latest post focuses on negotiating holdover provisions. Holdover provisions should be carefully negotiated in order to limit a tenant’s liability for expenses arising from unforeseen circumstances.

What happens if a tenant does not vacate on lease expiration without having negotiated a renewal or a new lease? Circumstances may arise which interfere with a tenant’s ability to vacate premises in a timely manner, such as delays in new space being ready for occupancy or delayed or terminated negotiations with respect to a lease for intended new space.

On June 13, 2024, a unanimous Supreme Court held that physicians and medical associations opposed to abortion lacked standing to challenge the U.S. Food and Drug Administration’s (FDA’s) approval of the drug mifepristone, which is primarily used in terminating pregnancy. The Court’s decision in FDA v. Alliance for Hippocratic Medicine affirms the status quo—mifepristone will remain available to patients without in-person dispensing requirements and for pregnancies up to 10 weeks.

In April 2023, the U.S. District Court for the Northern District of Texas ruled that the physicians and medical associations in this case did have standing to sue the FDA for approving mifepristone in 2000. Based on that standing, the District Court determined that the FDA’s approval of mifepristone was invalid under the Administrative Procedure Act and enjoined the FDA’s original approval. The District Court delayed its decision for seven days and, as we have previously discussed on this blog, set off a flurry of filings before the Fifth Circuit and Supreme Court, ultimately leading the latter to issue a stay on the District Court’s injunction of the FDA’s original approval of mifepristone. The stay allowed mifepristone to remain on the market under its current approval and remained in effect through the June 13, 2024 decision by the Court.

Distressed businesses are often compared to melting ice cubes or an aircraft in rapid descent. The goal for a distressed business is to get to a transaction before the ice cube melts or the aircraft and ground meet at an unsurvivable speed. New state laws modeled after the federal Hart-Scott-Rodino (HSR) Act now require, or will soon require, parties to provide notice of certain health care transactions to state regulators creating additional hurdles for distressed healthcare businesses.

Most people have seen the growth in artificial intelligence/ machine learning (AI/ML)-based medical devices being cleared by FDA.  FDA updates that data once a year at the close of its fiscal year.  Clearly the trend is up. But that's a bit backward looking, in the sense that we are only learning after the fact about FDA clearances for therapeutic applications of AI/ML.  I want to look forward.  I want a leading indicator, not a laggard.

I also want to focus on uses of AI/ML that are truly therapeutic or diagnostic, as opposed to the wide variety of lifestyle and wellness AI/ML products and the applications used on the administrative side of healthcare.  As a result, in this post I explore the information on clinicaltrials.gov because not only are those data focused on the truly health related, they are also forward-looking. The more recent clinical trials involve products still under investigation and not yet commercially available or even submitted to FDA.

In April, we shared with you our thoughts on what to consider before opening in or investing in a medical spa, thinking about corporate structure, scope of practice, licenses and registrations, referral restrictions, HIPAA and data privacy, and more. This month, we’re focusing on how states are beginning to regulate in this area, so owners and operators can hit the ground running in terms of compliance—or relax and breathe deep, knowing they are ahead of the plan. 

In March 2024, the state of Rhode Island introduced S 2870, the Medical Spas Safety Act, providing (within the definition of “cosmetic medical procedure”) that:

• The performance of cosmetic medical services is the practice of medicine and surgery; and
• A cosmetic medical service shall be performed by a qualified licensed or certified non-physician only if the services have been delegated by a medical director, supervising physician, supervising physician’s assistant (PA) or supervising advanced practice registered nurse (APRN) who is responsible for onsite supervision of services performed.

On May 25, 2024, Louisiana Governor Jeff Landry signed a bill, SB 276, into law that will classify medications commonly used in pregnancy and to treat stomach ulcers (mifepristone and misoprostol) as controlled substances. The provision classifying mifepristone and misoprostol as controlled substances was added in an amendment to SB 276 to make “coerced” abortions unlawful in the state. The new law is scheduled to take effect on October 1, 2024.

SB 276 represents the first attempt by a state to categorically restrict certain types of medication because they can be used for abortion. Many states have laws restricting the prescription and dispensing of drugs determined to be “abortion-inducing drugs,” but such drugs are only restricted if they are intended to be used to produce an abortion.[1] The laws restricting “abortion-inducing drugs” left open the ability of medical professionals to prescribe these drugs without restriction for non-abortion purposes, such as managing the effects of miscarriage or, in the case of misoprostol, preventing stomach ulcers. Now, due to these drugs’ association with abortion, they will be subject to new restrictions in the state and may impact the treatment of conditions unrelated to abortion.

State governments are increasingly entering the field of health care market oversight and enforcement. In what was once an issue typically left to the federal government, state governments are looking for ways to regulate market activity in the health care industry as a way to stem increases in health care costs. Late May brought yet another example of what the future may offer in this regard.

Think you’re being healthy when you reach for that KIND bar in the middle of your workday? We won’t say yes or no—since the U.S. Court of Appeals for the Second Circuit has recently declined to opine on what “all natural” means—or to hear from experts on the matter.

On May 2, the Second Circuit held that the U.S. District Court for the Southern District of New York did not err in throwing out a class action suit against KIND, LLC based on the use of the term “all natural.”[1] The company, of course, markets, advertises, and distributes snack foods including that Caramel Almond & Sea Salt bar that got you through the afternoon.

The district court granted KIND’s motion for summary judgment in September 2022, holding that the plaintiffs (consumers) had failed to establish how a reasonable consumer would understand the term “all natural.”

The Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health Organization to eliminate the federal constitutional right to abortion continues to alter the legal landscape across the country. On April 26, 2024, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) published the “HIPAA Privacy Rule to Support Reproductive Health Care Privacy” (the “Final Rule”).

The Final Rule—amending the Standards for Privacy of Individually Identifiable Health Information (“Privacy Rule”) under the Health Insurance ...